MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD CANNULA INTERLINK THREADED LOCK; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303369
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd cannula interlink threaded lock, the device experienced flow issues.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: this is a report about a flow issue.According to the customer's verbatim report, the hcp connected a threaded lock cannula to the injection site of a2n3374-zba but the fluid didn't flow.The hcp then used another threaded lock cannula but the fluid still didn¿t flow.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd cannula interlink threaded lock, the device experienced flow issues.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: this is a report about a flow issue.According to the customer's verbatim report, the hcp connected a threaded lock cannula to the injection site of a2n3374-zba but the fluid didn't flow.The hcp then used another threaded lock cannula but the fluid still didn¿t flow.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2022-02-04.H6: investigation summary: four pictures and one sample of a thread lock component (p/n 303369) from batch # 1082816 were received and evaluated.No blockage observed from photos and physical sample received.Since the reported defect was not identified in the samples received, a potential root cause could not be defined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
It was reported when using the bd cannula interlink threaded lock, the device experienced flow issues.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: this is a report about a flow issue.According to the customer's verbatim report, the hcp connected a threaded lock cannula to the injection site of a2n3374-zba but the fluid didn't flow.The hcp then used another threaded lock cannula but the fluid still didn¿t flow.

• Brand Name: BD CANNULA INTERLINK THREADED LOCK
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13403002
• Report Number: 1213809-2022-00025
• Device Sequence Number: 11986408
• Product Code: FMI
• UDI-Device Identifier: 00382903033690
• UDI-Public: 00382903033690
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: 303369
• Device Lot Number: 1082816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown